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Compliance-ready comprehensive solutions for nitrosamine impurity analysis
Ensuring accurate nitrosamine impurity analysis requires sensitive and reliable methods. Thermo Fisher Scientific provides advanced solutions that meet global regulatory standards, delivering confidence in both exploratory and routine testing. Our comprehensive portfolio includes chromatography for robust separation, HRAM spectrometry for precise detection and reduced false positives, tandem mass spectrometry (MS/MS) for reliable routine analysis, and compliance-ready software for seamless integration. With these technologies, we can help you can achieve accurate, efficient, and compliant nitrosamine testing.
The Thermo Scientific Chromeleon Chromatography Data System (CDS) streamlines chromatography and mass spectrometry workflows, reducing manual intervention while meeting FDA 21 CFR Part 11, ICH Q2(R2), and EMEA guidelines. With built-in audit trails, electronic signatures, and automated reporting, Chromeleon CDS accelerates method development and validation, helping to ensure accuracy, efficiency, and confidence in critical analyses like nitrosamine impurity testing.
Chromeleon CDS automates workflows, ensuring compliance and accuracy in critical analyses.
Accurate identification and monitoring of nitrosamine impurities are essential for pharmaceutical safety. Nitrosamines have been found in drugs like angiotensin II receptor blockers and metformin, highlighting the need for thorough risk assessments. Evolving regulations ensure the use of precise tools for confident analysis, helping laboratories meet compliance and protect patient health.
Helping to ensure safety through precise identification and monitoring of nitrosamine impurities in pharmaceuticals.
Achieve fast, reliable nitrosamine screening with advanced LC-MS/MS solutions designed for high-throughput, routine workflows. The Thermo Scientific TSQ Quantis Plus Triple Quadrupole Mass Spectrometer delivers exceptional sensitivity, robustness, and ease of use, ensuring precise detection even in complex samples. With superior reproducibility, extended instrument uptime, and seamless lab integration, these solutions maximize efficiency and confidence in nitrosamine impurity analysis.
Achieve fast, reliable screening with advanced LC-MS/MS technology designed for routine workflows.
Automate sample preparation for nitrosamine impurity analysis with the Thermo Scientific TriPlus RSH SMART Autosampler, reducing manual steps like extraction, clean-up, and derivatization. By minimizing handling errors and environmental contamination, it enhances efficiency and accelerates GC-MS and LC-MS workflows, cutting the time spent on chromatographic analysis.
Help ensure error-free sample handling, reduce manual steps, and prevent contamination.
Nitrite impurities in excipients can lead to nitrosamine formation during manufacturing and storage, making their accurate detection essential for drug safety. Thermo Fisher Scientific’s ion chromatography portfolio, including Reagent-Free (RFIC) technology, enables precise nitrite quantification even in high-chloride environments. These advanced solutions help pharmaceutical companies control impurities, ensure compliance, and maintain product quality.
Quantify nitrite impurities. Safeguard drug products. Control nitrosamine formation.
For Research Use Only. Not for use in diagnostic procedures.